WHY ENROLL IN A CLINICAL TRIAL?
Scientists are constantly searching for better ways of dealing with cancer. This search is done in the form of clinical trials.
A clinical trial is an evaluation of a new way of managing cancer—with a new drug, a new procedure or a new diagnostic tool.
You may be reluctant to participate in what you might think is just an “experiment” with you as the “laboratory rat.” Nothing could be further from the truth. Clinical trials are conducted according to very specific guidelines developed by highly trained specialists, and carried out in steps, or phases.
Phase I trials assess the safety of the treatment.
Phase II assess the effectiveness. Patients are carefully monitored for improvement and for side effects.
Phase III trials are conducted on thousands of patients in centers across the country. To reach this stage the treatment method or drug must have demonstrated that it offers potential benefits, without unacceptable risks.
The patients are selected according to very specific criteria—age, stage of cancer, previous treatment, and so on, then divided into two groups by a random, computerized system. One group, called the treatment group, receives the new treatment. The other group, called the control group, receives whatever is considered the best suited current treatment.
Every trial is conducted according to a protocol—a set of guidelines that spells out exactly what will be done and when. The trial is stopped if there are unacceptable side effects, or if it becomes obvious early on that either the new or the old treatment is definitely superior. If the clinical trial confirms the benefits, the drug or treatment will be made available to all patients.
Where to Find a Clinical Trial?
If your physician does not mention trials, you may want to bring up the subject on your own. How and where can you find a trial that is appropriate for you? Generally, you or your physician can obtain information about ongoing trials from the National Cancer Institute’s hotline called PDQ.
Another excellent source is the www.ClinicalTrials.gov site. While this site is intended primarily for professionals, it offers user-friendly search features and lists over 100,000 ongoing trials. Simply enter the type of cancer you have, and the area where you live, and you will find the contact information and the status of the trial.
You may also choose to contact the Colon Cancer Alliance (CCA), which offers the service of trained professionals to do the searching for you.
If you consider a trial, the professionals conducting it will describe the details for you. If you decide to enroll, you will be asked to sign an informed consent form, to show that you understand the issues involved, the expected benefits, the possible side effects, your rights and responsibilities, and the possible outcome.
You will be asked to follow the schedule of treatments and tests as closely as possible, in order to make the information obtained scientifically sound, but you can choose to withdraw from the trial at any time.